bbluv Rino Pro Bedienungsanleitung Seite 6

EN FR ES IT
APPLIED STANDARDS:
The following standards apply to the design and manufacture of
the device:
• IEC/EN 60601-1 Medical Electrical Equipment – Part 1: General
requirements for basic safety and essential performance
• IEC/EN 60601-1-2 Medical electrical equipment – Part
1-2: General requirements for basic safety and essential
performance – Collateral Standard: Electromagnetic
compatibility – Requirements and tests
• IEC/EN 60601-1-6 Medical electrical equipment – Part 1-6:
General requirements for safety – Collateral standard: Usability
• IEC/EN 60601-1-11 Medical electrical equipment – Part
1-11: General requirements for basic safety and essential
performance – Collateral Standard: Requirements for medical
electrical equipment and medical electrical systems used in
the home healthcare environment
• EN ISO 10993-5 Biological evaluation of medical devices - Part
5: Tests for in vitro cytotoxicity
• EN ISO 10993-10 Biological evaluation of medical devices - Part
10: Tests for skin sensitization
• EN ISO 10993-23 Biological evaluation of medical devices - Part
23: Tests for irritation
DE PT
Rinö Pro